In today’s dialogue, we are privileged to converse with Bruce Hellman from uMotif, a company at the forefront of reshaping patient-centric design in clinical trials. With a rich history and a commitment to enhancing the user experience for patients and sponsors, uMotif offers a refreshing perspective on how technology and patient-centric designs can harmoniously coexist. Dive into our discussion as Bruce unravels uMotif’s journey, its challenges, successes, and the roadmap for the future of clinical trials.
Moe Alsumidaie: Bruce, taking a leaf from uMotif’s inception, it’s evident that the company has always been about the patient. Can you walk us through how this philosophy was foundational, especially during your early interactions with Parkinson’s patients?
Bruce Hellman: Certainly, Moe. Our inception in 2012 was marked by a poignant interaction with two Parkinson’s patients. Their excitement and validation of our approach were pivotal. It wasn’t just about tracking health; it was about understanding and managing their healthcare journey. From those early days, we’ve been unwavering in our commitment to prioritizing the patient’s journey, ensuring they have tools that not only aid in their healthcare but also capture data invaluable to medical practitioners and clinical trials. This patient-first approach starkly contrasts with the traditional industry norm, where often the protocol takes precedence over the patient’s experience.
Moe Alsumidaie: Ensuring data integrity, especially globally, is undoubtedly challenging. Can you share some insights on uMotif’s experiences in China, Japan, and Korea?
Bruce Hellman: Navigating the global landscape, with its diverse regulatory requirements, is indeed a challenge. We’ve made strides in over 30 countries, including China, Japan, and Korea. Each region has its unique requirements. For instance, data hosting in mainland China has its intricacies. Our emphasis has always been on ensuring data is hosted appropriately while maintaining the essence of the data. Additionally, our engagement with patients worldwide has taught us that while regulatory compliance is paramount, the human aspect, like a simple ‘thank you’, plays a pivotal role in patient-centric compliance and retention.
Moe Alsumidaie: Operational burdens, especially amid intricate protocols, are escalating. Could you elaborate on uMotif’s stance on the perceived burden?
Bruce Hellman: There is an analogy we often refer to. Imagine two scenarios: waiting for two hours for a flight with complete information versus an uncertain wait of an hour and 45 minutes. The former, despite being longer, feels less burdensome due to the clarity and communication. Translating this to clinical trials, providing timely updates and information can significantly alleviate the perceived burden. A patient, when informed and valued, is more likely to be compliant and engaged, even if the volume of data or questionnaires they have to manage is high.
Moe Alsumidaie: The term ‘decentralized clinical trials’ is gaining momentum. How does uMotif’s approach to data harmonization fit into this evolving landscape?
Bruce Hellman: Decentralized trials, or as some now refer to them, digital or hybrid trials, are reshaping the industry. Our goal is to provide a seamless experience, regardless of the geographical or logistical constraints. Ensuring consistent data capture, irrespective of country or language, is at the core of our approach. We’ve built mechanisms to link data sets using a standard methodology, ensuring global consistency. While challenges like variations in electronic medical records across countries persist, our approach prioritizes globally harmonized methods for data.
Moe Alsumidaie: Keeping participants engaged, especially in a decentralized setup, is paramount. How does uMotif ensure this continuous engagement?
Bruce Hellman: Our history gives us a unique advantage. Before venturing into research, we were deeply rooted in healthcare, focusing on aiding patients in their health journeys. This foundation has ingrained in us the significance of continuous engagement. Take, for instance, our chronic pain study. Participants engaged almost daily for six months, not just because of our user-friendly app but because we fed their data back to them, making it a mutually beneficial experience.
Moe Alsumidaie: Lastly, Bruce, with the sheer volume of data in clinical trials, real-time monitoring becomes crucial. How does uMotif’s platform ensure trials stay on track?
Bruce Hellman: Real-time monitoring is the backbone of successful clinical trials. Our robust reporting suite, tailored to diverse roles, provides stakeholders real-time data access. This, combined with alerts and proactive feedback mechanisms, allows swift interventions and course corrections. We believe in proactive patient-centric feedback, and by seeking inputs from both participants and clinicians during the trial, we ensure the study remains on the desired trajectory.